Form FDA 483

Results: 519



#Item
91Pharmaceuticals policy / Health / Food and Drug Administration / Food safety / Good manufacturing practice / Office of Criminal Investigations / Validation / Regulation of food and dietary supplements by the U.S. Food and Drug Administration / Form FDA 483 / Pharmaceutical sciences / Pharmaceutical industry / Pharmacology

PDF Document

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Source URL: www.fda.gov

Language: English
92Food and Drug Administration / Piperazines / Pharmaceuticals policy / Otologicals / Ciprofloxacin / Pefloxacin / Prescription medication / Ofloxacin / Form FDA 483 / Pharmacology / Medicine / Pharmaceutical sciences

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER_FOR DRUG EVALUATION AND RESEARCH 7520 Standish Place-Room 254 Rockville, Maryland 20855

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93Food and drink / Food Safety Modernization Act / Federal Food /  Drug /  and Cosmetic Act / Center for Food Safety and Applied Nutrition / Dietary supplement / Food safety / Food Safety and Modernization Act / Form FDA 483 / Food and Drug Administration / Health / Medicine

Contains Nonbinding Recommendations Guidance for Industry What You Need To Know About Registration of Food Facilities Small Entity Compliance Guide

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Language: English
94Food law / Food and drink / Adulteration / Pharmaceuticals policy / United States Public Health Service / Federal Food /  Drug /  and Cosmetic Act / Food Safety and Modernization Act / Form FDA 483 / Food and Drug Administration / Health / Medicine

Appendix A: Medical Gas Partnership Agreement I. PURPOSE AND GOALS This Partnership Agreement (Agreement) establishes a cooperative program between two entities (individually a Party -- collectively the Parties): The Foo

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Source URL: www.fda.gov.

Language: English
95Pharmaceutical sciences / Form FDA 483 / Center for Biologics Evaluation and Research / Office of Regulatory Affairs / Center for Drug Evaluation and Research / Good manufacturing practice / Center for Devices and Radiological Health / Biologic / Center for Food Safety and Applied Nutrition / Food and Drug Administration / Medicine / Health

Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP U.S. Department of Health and Human Services

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Language: English
96Science / Dendreon / Measurement / Technology / Quality / Cancer vaccines / Validation / Verification and validation / Form FDA 483 / Pharmaceutical industry / Validity / Food and Drug Administration

BLA[removed]Resubmission CMC Review of Complete Response Letter Items (Including 483 items) and Additional Information Not Contained in Original Submission - Provenge

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Language: English
97Food safety / Foodborne illness / Food and Drug Administration / Botulism / Form FDA 483 / Shelf life / United States salmonellosis outbreak / United States listeriosis outbreak / Health / Food and drink / Medicine

CHAPTER 8 - INVESTIGATIONS

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Language: English
98Food law / Food and drink / Adulteration / Pharmaceuticals policy / United States Public Health Service / Federal Food /  Drug /  and Cosmetic Act / Food Safety and Modernization Act / Form FDA 483 / Food and Drug Administration / Health / Medicine

Appendix A: Medical Gas Partnership Agreement I. PURPOSE AND GOALS This Partnership Agreement (Agreement) establishes a cooperative program between two entities (individually a Party -- collectively the Parties): The Foo

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Source URL: www.fda.gov.

Language: English
99Pharmacology / Pharmaceutical sciences / Clinical research / Design of experiments / Drug safety / Institutional review board / Form FDA 483 / Clinical trial / Investigational New Drug / Food and Drug Administration / Medicine / Health

Institutional Review Boards Chapter 48 - Bioresearch Monitoring

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Language: English
100Clinical research / Medicinal chemistry / Food and Drug Administration / Form FDA 483 / Pharmaceutical sciences

IOM 2014 CHAPTER 5 - ESTABLISHMENT INSPECTIONS

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Language: English
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